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Last Updated: April 22, 2021

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RIOMET Drug Profile

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Which patents cover Riomet, and what generic alternatives are available?

Riomet is a drug marketed by Ranbaxy and Sun Pharm and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eighteen patent family members in eighteen countries.

The generic ingredient in RIOMET is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Seventy-nine suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Riomet

A generic version of RIOMET was approved as metformin hydrochloride by ATLAS PHARMS LLC on January 24th, 2002.

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Drug patent expirations by year for RIOMET
Drug Prices for RIOMET

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Drug Sales Revenue Trends for RIOMET

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Recent Clinical Trials for RIOMET

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SponsorPhase
St. Jude Children's Research HospitalPhase 2
St. Baldrick's FoundationPhase 2
Innovent Biologics (Suzhou) Co. Ltd.Phase 2

See all RIOMET clinical trials

Pharmacology for RIOMET
Drug ClassBiguanide
Paragraph IV (Patent) Challenges for RIOMET
Tradename Dosage Ingredient NDA Submissiondate
RIOMET SOLUTION;ORAL metformin hydrochloride 021591 2018-02-02

US Patents and Regulatory Information for RIOMET

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ranbaxy RIOMET metformin hydrochloride SOLUTION;ORAL 021591-001 Sep 11, 2003 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sun Pharm RIOMET ER metformin hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 212595-001 Aug 29, 2019 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for RIOMET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 C 2008 016 Romania   Start Trial PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408
1261586 2012C/016 Belgium   Start Trial PRODUCT NAME: UNE COMBINAISON DE PRODUITS DE SAXAGLIPTINE ET DE METFORMINE AINSI QUE TOUT SELS PHARMACEUTIQUEMENT ACCEPTABLES, DONT LES SELS DE CHLORHYDRATE DE SAXAGLIPTINE ET DE METFORMINE; AUTHORISATION NUMBER AND DATE: EU/1/11/731/001 20111128
1261586 15/2012 Austria   Start Trial PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
1532149 CA 2013 00001 Denmark   Start Trial PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
1412357 PA2008013,C1412357 Lithuania   Start Trial PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
McKinsey
Baxter
Moodys
Merck

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